Matrix CR 2050, Pmi 3000
FDA 510(k) K925289 · Heraeus Kulzer, Inc.
510(k) numberK925289
Submission
- Device name
- Matrix CR 2050, Pmi 3000
- Applicant
- Heraeus Kulzer, Inc.
Orangeburg, NY, US - Received
- October 21, 1992
- Decision date
- April 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Matrix CR 2050, Pmi 3000 cleared by the FDA?
Matrix CR 2050, Pmi 3000 (K925289) received a 510(k) decision of Substantially Equivalent on April 8, 1993, 169 days after the submission was received.
What is the product code of K925289?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.